FDA Warns of Bogus Claims by Makers of Hand Sanitizer

No evidence hand-sanitizing products can protect consumers for 24 hours or after multiple hand washings

MONDAY, April 27, 2020 (HealthDay News) — Some companies are selling hand sanitizers with unproven claims that they will protect against COVID-19, the U.S. Food and Drug Administration warns.

Last week, the agency issued its first warning letter for a hand sanitizer marketed with unproven COVID-19-related claims that violated federal law. The letter was issued to Prefense, LLC, for making misleading statements about its hand sanitizer, such as “Prefense protects you from germs with just one application per day! It’s like wearing an invisible glove.” The company’s website also wrongly claims that Prefense can “protect you from pathogens up to 24 hours or for 10 hand washes,” according to an FDA news release. There is no evidence that hand-sanitizing products can protect consumers for 24 hours or after multiple hand washings, the FDA said.

The FDA turned to manufacturers in an attempt to meet demand for alcohol-based hand sanitizer. So far, more than 1,500 additional manufacturers have registered with the FDA to produce the hand cleaners. But that has led to safety concerns about false marketing or products that are not in line with FDA policies. One safety precaution with alcohol-based hand sanitizer is the use of denatured alcohol. This makes the sanitizer bitter-tasting and less appealing to children. Consuming just a small amount of hand sanitizer may be potentially deadly in a young child. This month, the FDA received a report of a 13-year-old child drinking hand sanitizer that was packaged in a liquor bottle from a distiller. The sanitizer was not denatured and was reported to taste like normal drinking alcohol.

Hand sanitizer-related calls to the National Poison Data System last month were 79 percent higher than in March 2019. The majority of the calls last month were for unintentional exposures in children aged 5 years and younger, the FDA said.